MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for DRIVE 12202KD-1 manufactured by Zhnongshan Bliss.
[139615707]
(b)(4) is the initial importer of the device which is a shower chair. The chair was used by a hotel for clients. It was approximately 3 years old. The incident was reported to drive pms team by the hotel's insurance company. The client was using the shower chair when the legs reportedly bent and the client fell. He sustained injuries that are as yet unclear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00011 |
| MDR Report Key | 8445526 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-01-19 |
| Date Facility Aware | 2019-01-30 |
| Report Date | 2019-03-22 |
| Date Reported to FDA | 2019-03-22 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | SHOWER CHAIR |
| Product Code | ILS |
| Date Received | 2019-03-22 |
| Model Number | 12202KD-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHNONGSHAN BLISS |
| Manufacturer Address | 98, ZHAOYI ROAD, DONGSHENG TTOWNSHIP ZHONGSHAN CITY,, GUANGDONG, 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |